Aetna considers transcutaneous electrical acupoint stimulation (prescription version ReliefBand devices) medically necessary for the treatment of post-operative nausea and chemotherapy-induced nausea that is unresponsive to antiemetics and other conservative therapies.
Aetna considers transcutaneous electrical acupoint stimulation (prescription version PrimaBella or ReliefBand devices) medically necessary for the treatment of hyperemesis gravidarum that is unresponsive to other conservative medical therapy (e.g., change in diet, ginger capsules, vitamin B6).
Aetna considers transcutaneous electrical acupoint stimulation (prescription version ReliefBand devices) experimental and investigational for the prevention of motion sickness because its effectiveness for this indication has not been established.
Aetna considers transcutaneous electrical acupoint stimulation experimental and investigational for improving pregnancy rates in women undergoing in-vitro fertilization because the effectiveness of this approach has not been established.
Aetna considers transcutaneous electrical acupoint stimulation experimental and investigational for muscle spasticity following brain injury because the effectiveness of this approach has not been established.
Note: Aetna does not cover over-the-counter disposable ReliefBand devices, which are used for the treatment of motion sickness, because they do not meet Aetna’s definition of durable medical equipment.Background
The ReliefBand (Neurowave Medical Technologies, Chicago, IL) is a watch-like device worn on the ventral side of the wrist. When activated, the device emits a low-level electrical current across 2 small electrodes on its underside, stimulating the median nerve (an acupuncture point). The ReliefBand offers 5 stimulation levels from the rotary dial that one can control to provide maximum comfort and relief. The non-invasive and drug-free ReliefBand is available by prescription for the treatment of nausea and vomiting (NV) due to pregnancy (PrimaBella, Alaven Pharmaceutical LLC, Marietta, GA), chemotherapy-induced NV, post-operative nausea and vomiting (PONV), and over-the-counter for the treatment of motion sickness.
Studies have shown that the ReliefBand is effective in treating chemotherapy-induced NV and as effective as antiemetic medications in managing NV following surgery.
Lee and Done (1999) evaluated the effectiveness of non-pharmacologic techniques to prevent post-operative PONV by systematic review. These studies included acupuncture, electroacupuncture, transcutaneous electrical nerve stimulation, acupoint stimulation, and acupressure. The authors concluded that non-pharmacologic techniques were equivalent to commonly used antiemetic drugs in preventing vomiting after surgery. Non-pharmacologic techniques were more effective than placebo in preventing NV within 6 hours of surgery in adults, but there was no benefit in children.
In a single-center, randomized, double-blind, placebo- and sham-controlled study, White et al (2002) compared the effectiveness of the ReliefBand to ondansetron when utilized alone or in combination for preventing PONV following plastic surgery (n = 120). Patients were randomly assigned to 3 prophylactic antiemetic treatment regimens with routine low-dose droperidol prophylaxis: (i) ondansetron (n = 40): 4 mg intravenous (I.V.) ondansetron and a sham ReliefBand; (ii) acustimulation (n = 40): 2 ml I.V. saline and an active ReliefBand; and (iii) combination (n = 40): 4 mg I.V. ondansetron and an active ReliefBand. The incidences of PONV, as well as the need for "rescue" antiemetics, were determined at specific time intervals for up to 72 hours after surgery. The outcome variables assessed included recovery times, quality of recovery score, time to resumption of normal diet, and patient satisfaction with the prophylactic antiemetic therapy. Use of the ReliefBand in combination with ondansetron significantly reduced nausea (20 versus 50 %), vomiting (0 versus 20 %), and the need for rescue antiemetics (10 versus 37 %) compared with ondansetron alone at 24 hours after surgery. Furthermore, the ability to resume a normal diet (74 versus 35 %) within 24 hours after surgery was significantly improved when the ReliefBand was used to supplement ondansetron (versus ondansetron alone). Finally, the quality of recovery (90 +/- 10 versus 70 +/- 20) and patient satisfaction (94 +/- 10 versus 75 +/- 22) scores were significantly higher in the combination group than the ondansetron group. There were no significant differences between the ReliefBand and ondansetron when administered as adjuvants to droperidol for antiemetic prophylaxis. The authors concluded that the ReliefBand compared favorably to ondansetron when used for prophylaxis against PONV.
In a randomized, double-blind, placebo- and sham-controlled study, Coloma et al (2002) compared the ReliefBand with ondansetron (Zofran) for the treatment of PONV after outpatient laparoscopic surgery (n = 268). All patients received antiemetic prophylaxis with metoclopramide, 10 mg I.V. or droperidol, 0.625 mg I.V. after induction of anesthesia. A total of 90 patients developed PONV in the recovery units and were randomized to 1 of 3 treatment groups: (i) the ondansetron group received 4 mg I.V. ondansetron and a sham ReliefBand; (ii) the acustimulation group received 2 ml I.V. saline and a ReliefBand; and (iii) the combination group received 4 mg I.V. ondansetron and a ReliefBand. A rescue antiemetic (10 mg I.V. metoclopramide) was administered only if the PONV symptoms persisted for 15 minutes or longer after initiating the treatment. A blinded observer recorded the recovery times, emetic symptoms, rescue antiemetics, maximum nausea scores, complete response to study treatment, and time to achieve discharge criteria. Post-discharge side effects, as well as patient satisfaction and quality of recovery scores, were assessed at 24 and 72 hours after surgery. The combination group had a significantly higher complete response rate than the acustimulation group (73 versus 40 %). In addition, fewer patients in the combination group experienced subsequent emetic events (8 compared to 18 in the acustimulation group). However, there were no significant differences between the 3 groups with respect to patient satisfaction and quality of recovery scores. The authors concluded that acustimulation with the ReliefBand can be used as an alternative to ondansetron for the treatment of established PONV.
Habib and colleagues (2006) examined whether transcutaneous acupoint electrical stimulation with the ReliefBand can prevent NV during and after cesarean delivery under spinal anesthesia. These investigators randomized 94 patients undergoing cesarean delivery with spinal anesthesia to receive the ReliefBand at the P6 point (active group) or an active ReliefBand applied to the dorsum of the wrist (sham control group). The ReliefBand was applied 30 to 60 mins pre-operatively and left in place for 24 hours. There was no statistically significant difference between the active and sham control groups in the incidence of intra-operative/post-operative nausea (30 % versus 43 %/23 % versus 41 %), vomiting (13 % versus 9 %/26 % versus 37 %), need for rescue antiemetics (23 % versus 18 %/34 % versus 39 %), or complete response (55 % versus 57 %/51 % versus 34 %). There was also no difference between the 2 groups in nausea scores, number of vomiting episodes, or patient satisfaction with PONV management.
In a randomized controlled study (n = 105), White et al (2005) reported that acustimulation with the ReliefBand was most effective in reducing PONV and improving patients' satisfaction with their antiemetic therapy when it was administered after surgery.
However, a Cochrane review on acupuncture-point stimulation (needles, electrical stimulation, magnets, or acupressure) for chemotherapy-induced NV (Ezzo et al, 2006) reported that non-invasive electrostimulation appears unlikely to have a clinically relevant impact when patients are given state-of-the-art pharmacological antiemetic therapy.
PrimaBella™ (Alaven Pharmaceutical LLC, Marietta, GA) is a neuromodulatory device that utilizes the same technology as the ReliefBand. It is intended for use in the treatment of NV due to pregnancy.
Slotnick (2001) evaluated the safety and effectiveness of P-6 acustimulation for the relief of NV associated with early pregnancy in 41 patients. Pre-treatment nausea severity, post-treatment nausea relief and device effectiveness were patient-rated using a 1 to 5 scale. All neonates were evaluated for congenital abnormalities. Pre-treatment nausea severity scores for treated patients averaged 4.2, with most severe and debilitating nausea rated 5. Post-treatment device effectiveness averaged 4.2, with significant or complete relief rated 5. Device ease of use averaged 4.3, with very easy to use rated 5. No congenital abnormalities were found. The authors concluded that because current pharmacologic treatments for nausea in early pregnancy are not consistent, efficacious or without un-wanted side effects or increased teratogenic risks, acustimulation of P-6 in pregnancy may prove to be a significant therapeutic alternative to current pharmacologic treatments for nausea in early pregnancy.
The American College of Obstetrics and Gynecology (ACOG, 2004) recommend a step-wise approach to alleviating NV in pregnancy, beginning with prevention at the time of conception. Two studies found that women who take a multi-vitamin at the time of conception were less likely to need medical attention for vomiting. While there is little published evidence regarding the efficacy of dietary changes for prevention or treatment of NV of pregnancy, a small study showed that protein meals were more likely to relieve NV of pregnancy than carbohydrate and fatty meals. Other conservative treatments recommended by ACOG included ginger capsules and electrical stimulation or acupressure at the P6 (or Neguian) point on the inside of the wrist. Women with more complicated NV of pregnancy may need pharmacologic therapy. While many conventional antiemetics have been used for NV of pregnancy, it is important to note that no drug has been approved by the FDA for the treatment of NV in pregnancy since Benedictine (an antiemetic no longer available in the U.S. but still widely used in Europe).
In the largest controlled clinical study of the Relief Band for motion sickness published to date (n = 77), Miller and Muth (2004) examined whether acupressure and acustimulation can prevent motion sickness, taking into consideration whether or not the acupressure and acustimulation are administered properly. These investigators found that neither band (the Acuband or the ReliefBand) nor placebo prevented the development of motion sickness, regardless of whether the bands were used correctly or incorrectly.
Zheng et al (2014) noted that the latest meta-analysis demonstrated that acupuncture improves pregnancy rates among women undergoing in-vitro fertilization-embryo transfer (IVF-ET), and surface acupoint stimulation, such as transcutaneous electrical acupoint stimulation (TEAS), may have the same or better potential. To explore the effect of TEAS on the clinical pregnancy rate (CPR) and live-birth rate (LBR) compared with real acupuncture and controls in women undergoing IVF, a multi-center, randomized controlled trial will be conducted. The inclusion criteria are the following: infertile women less than 40 years of age undergoing a fresh IVF or intra-cytoplasmic sperm injection cycle, and the study will be restricted to women with the potential for a lower success rate as defined by 2 or more previous unsuccessful ETs (fresh or frozen). Those who have severe illnesses possibly precluding IVF or pregnancy, have FSH levels greater than 20 IU/L, received donor eggs, had been previously randomized for this study or had undergone acupuncture (in any modality) as infertility treatment will be excluded. The subjects will be randomly assigned to the TEAS group (IVF + TEAS), the electro-acupuncture (EA) group (IVF + EA), or the control group (only IVF). A total sample size of 2,220 women is needed to detect differences in CPR among the 3 groups. Transcutaneous electrical acupoint stimulation or EA treatments will start once every 2 or 3 days from day 3 of menstruation in the ovarian stimulation cycle until the day of ET. The parameters of TEAS or EA will be the following: a frequency of 2/100 Hz, a moderate electrical current of 3 to 5 mA for TEAS and 0.8 to 1.0 mA for EA. The primary outcome is CPR; secondary outcomes are LBR, the number of oocytes aspirated and the total gonadotropin dose used in the stimulation cycle. The authors concluded that this study will provide significant evidence for using a new method (TEAS) in IVF.
Zhao et al (2015) evaluated the clinical safety and effectiveness of TEAS for the treatment of muscle spasticity after brain injury. A total of 60 patients with muscle spasticity after brain injury were randomized to the following 3 groups: 100, 2, and 0 Hz (sham) TEAS. The acupoints Hegu (LI4) -- Yuji (LU10) and Zusanli (ST36) -- Chengshan (BL57) on the injured side were stimulated at 0, 2, or 100 Hz; 5 times per week for 4 weeks. Patients were followed-up for 1 and 2 months after the treatments. The effects of the treatments on muscle spasticity at the wrist, thumb, the other 4 fingers, elbow, shoulder, knee, and ankle were evaluated by the Modified Ashworth Scale, and the effects on disability were assessed by the Disability Assessment Scale. The walking capability was evaluated by the Holden functional ambulation classification score. The overall performance was assessed by the Global Assessment Scale score and the improved Barthel Index. The safety of the treatments administered was also monitored. The wrist spasticity was significantly reduced from baseline at weeks 2, 3, and 4 of treatment and at the 1- and 2-month follow-up visits in the 100 Hz group (p < 0.01). Compared with 2 Hz or sham TEAS, 100 Hz TEAS decreased wrist spasticity at weeks 2, 3, and 4 of treatment and 1 month after treatment (p < 0.001). The other end-points were not affected by the treatments. No treatment-emergent adverse events were reported during treatments and follow-up visits. The authors concluded that TEAS appears to be a safe and effective therapy to relieve muscle spasticity after brain injury, although large-scale studies are needed to further verify the findings.
|CPT Codes / HCPCS Codes / ICD-10 Codes|
|Information in the [brackets] below has been added for clarification purposes.  Codes requiring a 7th character are represented by "+":|
|ICD-10 codes will become effective as of October 1, 2015:|
|CPT codes not covered for indications listed in the CPB:|
|97813||Acupuncture, 1 or more needles; with electrical stimulation, initial 15 minutes of personal one-on-one contact with patient|
|+97814||with electrical stimulation, each additional 15 minutes of personal one-on-one contact with the patient, with re-insertion of needle(s) (List separately in addition to code for primary procedure)|
|Other CPT codes related to the CPB:|
|97014||Application of a modality to one or more areas; electrical stimulation (unattended)|
|97032||Application of a modality to one or more areas; electrical stimulation (manual), each 15 minutes|
|HCPCS codes covered if selection criteria are met:|
|E0765||FDA approved nerve stimulator, with replaceable batteries, for treatment of nausea and vomiting|
|Other HCPCS codes related to the CPB:|
|G0283||Electrical stimulation (unattended), to one or more areas for indication(s) other than wound care, as part of a therapy plan of care|
|ICD-10 codes covered if selection criteria are met:|
|K91.0||Vomiting following gastrointestinal surgery|
|O21.0 - O21.9||Excessive vomiting in pregnancy|
|R11.0 - R11.2||Nausea and vomiting|
|T45.1X5+||Adverse effect of antineoplastic and immunosuppressive drugs [post-operative nausea and chemotherapy-induced nausea]|
|ICD-10 codes not covered for indications listed in the CPB:|
|M62.40 - M62.49||Contracture of muscle|
|N46.01 - N46.9||Male infertility|
|N97.0 - N97.9||Female infertility|
|S02.0XX+ - S02.92X+||Fracture of skull and facial bones|
|S06.0X0+ - 06.9X9+||Intracranial injury|
|Z31.83||Encounter for assisted reproductive fertility procedure cycle|
|Z31.89||Encounter for other procreative management|